Postoperative adjuvant radiochemotherapy with cisplatin versus adjuvant radiochemotherapy with cisplatin and pembrolizumab in locally advanced head and neck squamous cell carcinoma- the study protocol of the Adrisk trial

Wiegand, Susanne ; Wichmann, Gunnar ; Vogt, Jeannette ; Vogel, Kathrin ; Franke, Annegret ; Kuhnt, Thomas ; Lordick, Florian ; Scheuble, Anne-Marie ; Hambsch, Peter ; Brossart, Peter ; Bauernfeind, Franz Georg ; Kaftan, Holger ; Maschmeyer, Georg ; Paland, Matthias ; Münter, Marc ; Lewitzki, Victor ; Rotter, Nicole ; Stromberger, Carmen ; Beck, Marcus ; Dommerich, Steffen ; Gauler, Thomas Christoph ; Hapke, Gunnar ; Guntinas-Lichius, Orlando ; Schröder, Ursula ; Görner, Martin ; Hautmann, Matthias G. ; Steger, Felix ; Tamaskovics, Bálint ; Schmiedeknecht, Anett ; Dietz, Andreas

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Details

Item type:	Article
Journal or Publication Title:	Frontiers in Oncology
Publisher:	FRONTIERS MEDIA SA
Place of Publication:	LAUSANNE
Volume:	13
Date:	2023
Institutions:	Medicine > Lehrstuhl für Strahlentherapie
Identification Number:	Value Type 10.3389/fonc.2023.1128176 DOI
Keywords:	OPEN-LABEL; NCIC CTG; RISK; CHEMOTHERAPY; RADIOTHERAPY; RECURRENT; EORTC; RTOG; MULTICENTER; DELINEATION; head neck cancer; immunotherapy; pembrolizumab; immune checkpoint blockade PD-1:PD-L1 axis; upfront surgery; locoregional disease; randomized controlled phase IIB clinical trial
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	76203

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Abstract

Most of the patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. Standards of care for curative-intent treatment of this patient group are either surgery and adjuvant radio(chemo)therapy (aRCT) or definitive chemoradiation. Despite these treatments, especially pathologically intermediate and high-risk HNSCC often recur. The ADRISK trial ...

Abstract

Most of the patients with head and neck squamous cell carcinoma (HNSCC) are diagnosed with locally advanced disease. Standards of care for curative-intent treatment of this patient group are either surgery and adjuvant radio(chemo)therapy (aRCT) or definitive chemoradiation. Despite these treatments, especially pathologically intermediate and high-risk HNSCC often recur. The ADRISK trial investigates in locally advanced HNSCC and intermediate and high risk after up-front surgery if the addition of pembrolizumab to aRCT with cisplatin improves event-free survival compared to aRCT alone. ADRISK is a prospective, randomized controlled investiga-tor-initiated (IIT)-phase II multicenter trial within the German Interdisciplinary Study Group of German Cancer Society (IAG-KHT). Patients with primary resectable stage III and IV HNSCC of the oral cavity, oropharynx, hypopharynx and larynx with pathologic high (R1, extracapsular nodal extension) or intermediate risk (R0 <5 mm; N >= 2) after surgery will be eligible. Two hundred forty patients will be randomly assigned (1:1) to either standard aRCT with cisplatin (standard arm) or aRCT with cisplatin + pembrolizumab (200 mg iv, in 3-week cycle, max. 12 months) (interventional arm). Endpoints are event-free and overall survival. Recruitment started in August 2018 and is ongoing.

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